|
|
Pipeline Insight: Osteoporosis - Intermittent Dosing and Multiple Indications Drive Market GrowthPublished by: Datamonitor Published: Jan. 28, 2004 - 264 Pages Table of ContentsTABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Datamonitor insight into the osteoporosis market 4 Innovative bisphosphonates, Zometa (zoledronate) and Boniva (ibandonrate), with their novel dosing regimens and delivery methods, will drive growth in the osteoporosis market, as sales will reach $10.4 billion by 2011 5 Targeting compliance with intermittent dosing bisphosphonates 5 Driven by new market leader Evista (raloxifene), which will stay one step ahead of lead Pfizer’s lasofoxifene and Wyeth’s bazedoxifene by targeting multiple indications, the SERMs drug class will be valued at $4.2 billion by 2011 8 Expanding SERM market potential with additional indications 8 The osteoporosis early stage pipeline consists largely of drug candidates in new therapeutic classes, in particular cathepsin K inhibitors, osteoprotegerin and calcilytics. While these drugs have the potential to change the face of osteoporosis treatment in the long term, innovative approaches will likely be costly to patients, limiting potential 10 Summary 12 Key metrics 14 CHAPTER 2 PATIENT POTENTIAL 30 Definition of osteoporosis 30 Etiology of osteoporosis 31 Osteoporosis classification: primary and secondary 31 Pathology and complications 32 Drug targets in osteoporosis 33 Development of osteoporosis drugs 34 Epidemiology of osteoporosis 37 Methodological difficulties in assessing prevalence 38 Prevalence of osteoporosis and osteopenia in postmenopausal women 39 Overview of the prevalence of osteoporosis and osteopenia in postmenopausal women 40 US 42 Japan 43 France 44 Germany 44 Italy 45 Spain 45 UK 46 Segmentation of osteoporosis 46 Prevalence of osteoporosis and osteopenia in men 47 Introduction 47 Overview of the prevalence of osteoporosis/osteopenia in men 47 US 49 Japan 50 France 50 Germany 51 Spain 51 UK 52 Osteoporosis population forecast 52 Osteoporotic fractures, their implications and minor risk groups 53 Introduction 53 Limitations of fracture prevalence data 54 Overview of fracture prevalence 55 US 56 Japan 57 France 57 Germany 57 Italy 58 Spain 58 UK 59 Niche populations 60 Glucorticoid induced osteoporosis 60 Anorexia nervosa 61 HIV 61 CNS disorder related bone loss 62 Paget’s disease 62 Ethnic diversity 63 Premature menopause 63 Unmet need in osteoporosis 64 Clinical unmet need 64 Need for greater fracture reduction efficacy 65 Need for more bone-forming drugs 67 Need for improved compliance 68 Need for efficacy in surrogate endpoints 69 CHAPTER 3 R&D APPROACH 72 Classification of pipeline products 73 Bisphosphonates 73 Mechanism of action 73 Class breakdown 74 SERMs 75 Mechanism of action/technology or therapeutic premise 75 Calcitonins 76 Mechanism of action 76 Parathyroid hormone and analogues 77 Mechanism of action 78 Hormone therapy 78 Mechanism of action 78 Class breakdown 78 Clinical trial design in osteoporosis 79 Clinical trial guidelines 79 Pre-clinical planning: use of animal models 80 Prevention and treatment: the implications for endpoint selection 80 Trial design and study population 81 Trial design and implementation in osteoporosis: the future? 82 Problems with definitions: a need for greater consistency 82 Large-scale trials: can surrogate endopints ever predict fracture risk? 82 More effective recruitment and retention strategies are also needed 82 Evolution of osteoporosis drugs may impact trial recruitment 83 Clinical trial endpoints in osteoporosis 84 Fracture rate 85 Significance of fracture rate as an endpoint 85 Considerations with fracture endpoints 86 Changes in BMD 87 Significance of BMD as an endpoint 87 Limitations of BMD as a clinical trial endpoint 88 Biochemical markers of bone turnover 89 How useful are bone markers? 89 Limitations in the use of bone-specific markers 90 Changes in bone microarchitecture 90 Problems associated with microarchitecture assessment 91 CHAPTER 4 OSTEOPOROSIS PIPELINE ANALYSIS 93 Pipeline overview 94 Key companies involved in the osteoporosis pipeline 96 Novartis 96 Missing the bone-formation boat? 96 How will Novartis play the patent game? 97 GSK 98 Newcomer with a long-term approach 98 Merck - a notable absentee 99 Strategies for success in osteoporosis 100 Dosing variations in the bisphosphonate class 100 Multiple indications strategy in osteoporosis 101 CHAPTER 5 BISPHOSPHONATE LATE-STAGE DRUG ANALYSIS & FORECASTS 103 Overview for the bisphosphonate class 104 Pipeline summary 104 Definition of current comparator therapy 104 Clinical trial data 105 Comparative analysis 106 Bonviva (ibandronate) 106 Drug overview 106 Clinical trial data 107 Patient potential 113 Marketing factors 114 Satisfaction of unmet needs 117 Need for greater fracture reduction efficacy 117 Need for improved compliance 118 Need for drugs with bone forming properties 118 Need for surrogate endpoint efficacy 119 Forecasts to 2011 119 Zometa (zoledronate) 121 Drug overview 121 Clinical trial data 122 Patient potential 123 Marketing factors 125 Satisfaction of unmet needs 126 Need for greater fracture reduction efficacy 127 Need for improved compliance 127 Need for drugs with bone forming properties 128 Need for surrogate endpoint efficacy 128 Forecasts to 2011 129 Other late stage drugs 130 Minodronate 130 Apomine 130 Clodronate 131 Drug overview 131 Clinical data 131 Comparison of key compounds in the bisphosphonate class 133 Unmet needs 133 Fracture reduction efficacy 134 Compliance variables 135 Bone forming properties 135 Surrogate endpoint efficacy 136 Marketing strength 136 Comparative forecasts 136 CHAPTER 6 SERMS LATE-STAGE ANALYSIS AND FORECASTS 138 Overview table 139 Definition of current comparator therapy 139 Comparative analysis 141 Lasofoxifene 142 Drug overview 142 Clinical trial data 142 Patient potential 143 Marketing factors 144 Satisfaction of unmet needs 144 Need for improved compliance 145 Need for drugs with bone forming properties 145 Need for surrogate endpoint efficacy 146 Forecasts to 2011 146 Bazedoxifene 147 Drug overview 147 Clinical trial data 147 Bazedoxifene and premarin 148 Patient potential 148 Marketing factors 149 Satisfaction of unmet needs 150 Need for improved compliance 150 Need for drugs with bone forming properties 151 Need for surrogate endpoint efficacy 151 Forecasts to 2011 151 Other late stage drugs 153 Ospemifene 153 Drug overview 153 Comparison of key compounds in the SERM class 154 Unmet needs 154 Compliance variables 155 Bone forming properties 155 Surrogate endoint efficacy 156 Marketing strength 156 Comparative forecasts 157 CHAPTER 7 CALCITONIN LATE-STAGE DRUG ANALYSIS AND FORECASTS 158 Overview table 159 Definition of current comparator therapy 160 Overview 160 Clinical trial data 161 Comparative analysis 162 Fortical 162 Drug overview 162 Clinical trial data 162 Patient and marketing potential 164 Satisfaction of unmet needs 164 Forecasts to 2011 165 Other drugs in the calcitonin class 167 SMC021 167 Drug overview 167 Clinical trial data 167 rsCT 168 Drug overview 168 Clinical trial data 168 CHAPTER 8 PTH LATE-STAGE DRUG ANALYSIS AND FORECASTS 170 Overview for PTH class 171 Definition of current comparator therapy 171 Comparative analysis 173 Preos (rhPTH 1-84) 173 Drug overview 173 Clinical trial data 173 Patient potential 176 Marketing factors 177 Satisfaction of unmet needs 178 Need for improved compliance 179 Need for drugs with bone forming properties 179 Need for surrogate endpoint efficacy 180 Forecasts to 2011 181 Other drugs in the PTH class 182 Asahi teriparatide/PTH (1-34) 182 Comparative forecasts 182 CHAPTER 9 ‘OTHER’ DRUGS LATE STAGE ANALYSIS AND FORECASTS 183 Overview 184 Definition of current comparator therapy 184 Comparative analysis 184 Strontium ranelate 184 Drug overview 184 Clinical trial data 185 Patient potential 190 Marketing factors 191 Satisfaction of unmet needs 191 Need for greater fracture reduction efficacy 192 Need for improved compliance 192 Need for drugs with bone forming properties 193 Need for surrogate endpoint efficacy 193 Forecasts to 2011 193 Additional drugs in the ‘other’ class 194 Nitroflurbiprofen 194 Drug overview and clinical trial data 194 Patient potential, marketing factors and unmet needs 195 Osteoprotegerin 196 Drug overview 196 Clinical data 196 SomataKine (IGF 9606) 197 Drug overview 197 Clinical trial data 198 CHAPTER 10 INNOVATIVE EARLY-STAGE PROJECTS 201 Key phase I and preclinical compounds in osteoporosis 201 Cathepsin K inhibitors 202 Novartis - AAE581 202 Market potential 202 GSK - SB-462795 203 Merck/Celera 204 Calcilytics 204 GSK/NPS - 423557 204 Calcitonin 205 Nobex/Elan - Oratonin 205 PTH 206 Unigene/GSK 206 Src kinase inhibitors 206 Ariad 206 PPAR gamma modulators 207 GSK/Bayer 207 Vitronectin receptor antagonists 208 GSK - SB 273005 208 Long-acting proteins 208 Human Genome Sciences 208 Wyeth looking away from hormones to new horizons? 209 Key research impacts on osteoporosis 210 Impacts of clinical trial issues 211 CHAPTER 11 OPINION LEADER TRANSCRIPTS 213 Key opinion leader 1 - Belgium 213 Unmet needs 213 Pipeline 214 PTH 214 Bisphosphonates 216 SERMs 218 Calcitonins 219 Novel drug targets 220 Clinical trial design 221 Key opinion leader 2 - US 224 Unmet needs 224 PTH 227 Bisphosphonates 228 SERMs 231 Calcitonins 232 Clinical trial design 232 Key opinion leader 3 - US 236 Unmet needs 236 Pipeline 237 PTH 238 Bisphosphonates 239 SERMs 241 Calcitonins 242 Novel drug targets 243 Clinical trial design 244 Key opinion leader 4 - US 246 Unmet needs 246 Pipeline 248 PTH 248 Bisphosphonates 250 SERMs 251 Calcitonins 253 Novel drug targets 253 Clinical trial design 255 APPENDIX A 259 Contributing experts 259 Bibliography 259 Epidemiology 259 United States 259 Japan 260 France 260 Germany 261 Italy 261 Spain 262 UK 262 General 263 Clinical trial data 264 Report methodology 267 AbstractIntroductionOsteoporosis therapy has been largely focused on antiresorptive drugs that reduce the rate of bone loss. The condition is the focus of attention of significant R&D activity, with drugs in development both in existing classes offering advantages over marketed products and novel drugs exploiting genomics programs and a deeper understanding of bone biology. Scope Epidemiology of osteoporosis in the seven major markets by disease severity, identification of niche populations and unmet needs Detailed profiles of drugs in Phase II and above. Analysis examines clinical data, patient potential, marketing factors, satisfaction of unmet needs Primary research with key osteoporosis opinion leaders providing insight on future market entrants and innovative R&D projects in the disease area Pharma Market Forecast model shows market potential with global sales forecasts for key pipeline drugs, currently marketed products and classes Report Highlights Novel bisphosphonates, Zometa and Boniva, with their novel dosing regimens and delivery methods, will lead growth in the osteoporosis market, as R&D osteoporosis drugs will reach sales of $4.7 billion by 2011. Driven by new market leader Evista, which will lead Pfizer’s lasofoxifene and Wyeth’s bazedoxifene by targeting multiple indications, the SERMs drug class will be valued at $4.2 billion by 2011. The osteoporosis early stage pipeline consists largely of drug candidates in new therapeutic classes, in particular cathepsin K inhibitors, osteoprotegerin and calcilytics. While these drugs have the potential to change the face of osteoporosis treatment in the long term, innovative approaches will likely be costly to patients, limiting potential. Reasons to Purchase Validate internal forecasts against drug/class sales model and assess market potential for pipeline products Analyze competitive environment at time of product launch to inform best strategy for market entry Highlight key R&D trends and company involvement in the market to inform licensing decisions and identify potential partners based on R&D activity Get Full Details About This Report >> |
|
|||
|
About MarketResearch.com
|
||||